A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03281096|
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : July 27, 2022
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Adenomas||Drug: Berberine hydrochloride Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Trial of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer|
|Actual Study Start Date :||August 29, 2017|
|Actual Primary Completion Date :||October 12, 2020|
|Actual Study Completion Date :||March 1, 2021|
Experimental: Berberine hydrochloride group
Berberine hydrochloride 300mg tablet by mouth, two times per day for 3 years
Drug: Berberine hydrochloride
patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 3 years.
Other Name: Berberine hydrochloride tablet ("Sine Tianping")
Placebo Comparator: Placebo
identical-appearing placebo 300mg tablet by mouth, two times per day for 3 years
pill manufactured to mmic Berberine hydrochloride 100mg tablet
Other Name: Placebo (for Berberine hydrochloride)
- Cumulative the colorectal adenoma incidence rate during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer [ Time Frame: From baseline to 3 years. ]The proportion of patients in whom one or more colorectal adenomas were investigated during the period from one year after randomization through the anticipated surveillance follow-up examination. The development of colorectal adenomas was assessed with an Olympus flexible video colonoscopy. One endoscopic investigator, who did not review the records of previous examinations, made all the assessments.
- Cumulative the numbers or diameters of those new colorectal adenomas during Berberine hydrochloride or placebo treatment in patients with a history of colorectal cancer [ Time Frame: From baseline to 3 years. ]The numbers or diameters of those new colorectal adenomas were analyzed during the period from one year after randomization through the anticipated surveillance follow-up examination. The endoscopic investigator, who did not review the records of previous examinations, counted the total number of colorectal adenomas, and the examination was recorded on videotape. The diameter of those colorectal adenomas was measured in millimeters with a graduated scale passed through the colonoscopy biopsy channel.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281096
|Xijing Hospital of Digestive Disease|
|Xi'an, Shaanxi, China, 710032|
|Principal Investigator:||Weizhong Wang, MD,PH.D||Xijing digestive surgery center|